Khoso Baluch
Analyst · B. Riley FBR. Please proceed with your question
Thank you, Dan. Good afternoon, everyone, and thank you for joining us on this call. On today's earnings call, we will discuss several topics with you on the overall progress CorMedix is making in bringing DEFENCATH to the U.S. market for its first indication for use as a catheter lock solution for hemodialysis patients to prevent catheter-related bloodstream infections, with subsequent expansion into other indications. Joining me on this call are Phoebe and Matt. The three topics I will cover fall in the regulatory, financing and commercial area. First, as we disclosed several weeks ago, I'm very pleased by the submission to the FDA of the New Drug Application, or NDA, for DEFENCATH was completed in June. This submission was completed using the rolling submission format granted by the FDA, which we started in March. Completing this filing was a major undertaking as the team had to work through the Chemistry Manufacturing and Control information, CMC, and a large volume of data generated due to the size of LOCK-IT-100 trial and the underlying health issues of the hemodialysis patient group. This was the first NDA submitted by CorMedix and our goals, obviously, are to secure acceptance for filing of the NDA submission and then to obtain NDA approval from the FDA. I'm proud of the team at CorMedix for bringing their collective experience to bear and completing a high quality submission. Phoebe will provide more color during this call. We're also pleased to have recently completed an equity financing, consisting of $23 million in gross proceeds, including a full execution of the green show. The proceeds from this financing provides CorMedix the cash needed to continue the preparation required to launch DEFENCATH into the U.S. hemodialysis market following an approval from the FDA. CorMedix is appreciative of the effort from the team handling the financing and the opportunities to continue broadening our banking relationships. We were also pleased to see new life science-focused investors become shareholders as part of this transaction. We believe that completing an institutional financing, bringing in life science-focused investors and expanding our relationship with investment banking firms will serve to further strengthen CorMedix appeal to a broader audience of institutional finance investors. During this call, Matt will share more details about the goals we set out to achieve with this financing and additional details of what we have accomplished. I'd also like to provide an update on several work efforts that are moving forward with the goal of being prepared when we receive NDA approval, so that DEFENCATH can be launched into the U.S. hemodialysis market as soon as possible. In terms of market preparation, the team has been working on understanding DEFENCATH product characteristics that best draw the attention of payers, large dialysis organizations or LDOs, and health care professionals. Extensive primary market research and qualitative testing has been completed, and the value proposition for DEFENCATH is now being finalized for quantitative testing. The team has also defined the effort to properly size the sales force market access organization that will be required to best address these targeted LDOs, health care professionals and payer markets. This effort continues and will identify the national and regional accounts that CorMedix will target for the greatest returns. The market access team has been working with external payers to build the budgeting model that best address our respective needs. There's outreach ongoing with many dialysis service providers, both health care providers and payers. That is why we're so excited about the opportunity to bring our data to the Center of Medicare and Medicaid Services, CMS, which pays the health care cost for the majority of patients who are receiving hemodialysis. CMS pay for a significant amount of the cost of hemodialysis under its basic reimbursement program for end-stage renal disease patients referred to as the bundle; a fixed dollar reimbursement arrangement, which has historically acted as an unfortunate impediment to the adoption of new technology and better case strategy for patients undergoing hemodialysis. However, in recognition of this issue, CMS now has a relatively new program to accelerate the adoption of new treatments that can both improve patient care and/or reduce the cost of treating end-stage renal disease patients. This program is called TDAPA, which stands for transitional drug add-on payment adjustment, which allows for reimbursement of new technologies outside the bundle while the necessary utilization data are collected to determine how best to permanently incorporate the cost of these products in the CMS reimbursement regime. Now that the NDA is submitted, CorMedix will continue interacting with CMS to further our discussions about DEFENCATH inclusion into the TDAPA program. The official application requesting to be added to TDAPA can only occur after the FDA approval of the NDA. CorMedix has also focused on its goal of becoming a contributor member of several key patient health care providers advocacy organization focused on kidney care. The first one of the groups that we are focused with is called KCP, which stands for Kidney Care Partners, which is a national non-profit alliance of patient advocates, health care professionals and providers, aimed at just looking to develop community-wide policy position in an effort to ensure strong and unified advocacy on capital health and with several agencies, including kidney-related issues. The second one is DPC, which stands for Dialysis Patient Citizens, which is a nonprofit patient-led membership organization founded in April 2004 by end-stage renal disease patients who saw the need for an organization focused on advocacy and education for dialysis patients and their family. The effort will focus on sponsoring patient ambassadors who are dialysis patients who advocate for the need of dialysis patients with their legislatives both at the federal level in Congress and at state legislative level for including new drugs, devices and services. And the third organization is ANNA, which stands for American Nephrology Nurses Association, which is a nonprofit organization established in 1969 that has a membership of about 8,500 nephrology nurses. Members include registered nurses and other health care professionals with varied experiences and expertise in hemodialysis, home therapy, chronic kidney disease, continual renal replacement therapies, acute care and transplantation. CorMedix will continue to push ahead in preparation for the commercialization of DEFENCATH by reaching out to all the important stakeholders in the hemodialysis market to ensure that once DEFENCATH is approved by the FDA, it will be in the best possible position to successfully launch in the U.S. market. With that, now let me move to the second topic, which is the regulatory update. Phoebe?